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Search results for "fda recalls"

Found 10 results

FDA Recalls Tandem Diabetes Care’s t:connect Mobile App Due to Potential Health Risks

Insulin Pump App Malfunction Leads to Serious Safety Concerns The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most severe type of recall, for version 2.7 of Tandem Diabetes Care, Inc.’s t:connect mobile app. The app, which pairs with the t:slim X2 insulin pump with Control IQ technology, has caused...
Published on May 15, 2024

FDA Warnings & Eye Care Recalls: Safety Concerns Explained

Navigating the Recent FDA Warnings and Recalls on Eye Care Products Recent events have raised significant concerns about the safety of eye care products. The U.S. Food and Drug Administration (FDA) has issued a consumer advisory against purchasing or using 26 over-the-counter eye care products, including eyedrops from retailers such as CVS, Rite Aid, and...
Published on November 1, 2023

FDA Mandates First-Ever Asbestos Testing Requirements for Cosmetics

Federal Rule Requires Manufacturers to Screen Every Talc Product Batch The U.S. Food and Drug Administration announced comprehensive testing requirements for detecting asbestos in talc-containing cosmetics on December 26, 2024. The proposed regulation mandates specific scientific screening methods for all cosmetic products containing talc, implementing key 2022 Modernization of Cosmetics Regulation Act provisions. For the...
Published on January 9, 2025

FDA Issues Highest-Level Alert for Impella Heart Pump Linked to 49 Deaths

Impella Heart Pump Faces Scrutiny After FDA’s Highest-Level Alert The U.S. Food and Drug Administration (FDA) has issued its most serious type of recall for the Impella left-sided heart pumps, which are linked to 49 deaths and 129 injuries. The pumps, manufactured by Abiomed, temporarily support a patient’s heart during high-risk procedures or after a...
Published on March 30, 2024

Understanding the FDA’s Eye Drop Recall and Its Legal Implications

Understanding the FDA’s Eye Drop Recall and Its Legal Implications  In recent developments, the Food and Drug Administration (FDA) has issued a series of warnings and recalls for over-the-counter eye drop products. These recalls, affecting major brands and spanning a global scale, have raised significant concerns about the safety and regulatory oversight of such products....
Published on October 30, 2023

FDA Alert: MSM Eye Drops Contamination Risk

FDA Issues Critical Warning on Microbial Contamination in MSM Eye Drops The United States Food and Drug Administration (FDA) recently issued a critical warning about the use of specific eye drops, highlighting the presence of microbial contamination. This announcement has significant legal implications, particularly in terms of product safety, regulatory compliance, and consumer rights.   Key...
Published on August 23, 2023

The EzriCare Artificial Tears Recall: A Case Study in Pharmaceutical Safety and Regulatory Challenges

The EzriCare Artificial Tears Recall: An Insightful Overview The pharmaceutical industry recently faced a significant challenge that has highlighted crucial issues related to product safety and regulatory oversight. This article examines the recall of EzriCare Artificial Tears by the U.S. Food and Drug Administration (FDA) due to concerns of bacterial contamination. Manufactured by Global Pharma...
Published on August 25, 2023

Philips CPAP Information

What is a CPAP machine? Image: https://www.istockphoto.com/photo/sleep-apnea-oxygen-mask-equipment-gm1351786573-427406807?phrase=cpap A continuous positive airway pressure (CPAP) machine is a medical device commonly used to treat sleep apnea, characterized by interrupted breathing during sleep. CPAP therapy aims to maintain a steady flow of air into a patient’s airways, keeping these airways open and ensuring regular breathing patterns throughout the night. A...
Published on August 7, 2023

Exactech Lawsuit

The Exactech multidistrict litigation (MDL 3044) has grown to 1,770 pending cases in the U.S. District Court for the Eastern District of New York. On October 20, a stay on a transfer order was lifted, allowing 20 additional cases to be added to the MDL. No trials or settlements have been reached yet in this...
Published on July 10, 2023

J&J Proposes $8.9 Billion To Settle Talcum Powder Lawsuits

Johnson & Johnson Proposes $8.9 Billion To Settle Talcum Powder Lawsuits On April 4, 2023, Johnson & Johnson announced that it has earmarked $8.9 billion as part of a plan to cover settlements to tens of thousands of plaintiffs who allege the company’s talcum powder products caused cancer. This amount is more than four times...
Published on April 19, 2023
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